Spots Global Cancer Trial Database for Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
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Trial Identification
Brief Title: Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
Official Title: An Open-label, Multicentre, Phase II Study to Evaluate the Safety and Efficacy of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer
Study ID: NCT05009953
Study Description
Brief Summary: This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer.
Detailed Description: This is an open-label, parallel, multicentre, phase II study to evaluate the efficacy and safety of irinotecan liposome injection. Eligible patients will be divided into two cohorts according to the criteria for the corresponding cohort. The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV). The patients in cohort 2 will receive irinotecan liposome injection combined with a PD-1 inhibitor, 5-Fluorouracil and Leucovorin.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, China
Contact Details
Name: Xiangdong Cheng
Affiliation: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Role: PRINCIPAL_INVESTIGATOR
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